Evaluating semaglutide for fatty liver disease in real-world settings

Real-World Clinical Practice Study on the Effectiveness of Semaglutide Over 154 Weeks in Patients With Metabolic Dysfunction-Associated Fatty Liver Disease

This study is testing if the medication semaglutide can improve liver health in people with fatty liver disease and liver fibrosis over 154 weeks.

Quick facts

• Study type: Observational
• Enrollment: 70 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Center of target therapy (other)
• Locations: 1 site (Moscow)
• Trial ID: NCT06983171 on ClinicalTrials.gov

What this trial studies

This observational clinical trial assesses the effectiveness of semaglutide, administered at a target dose of 2.4 mg/week, over a period of 154 weeks in patients with metabolic dysfunction-associated fatty liver disease (MAFLD) and liver fibrosis. The study aims to gather real-world data on how semaglutide impacts liver health and metabolic markers in individuals with this condition, which is often linked to obesity and type 2 diabetes. Participants will undergo various assessments, including liver biopsies and non-invasive imaging tests, to evaluate changes in liver fat, inflammation, and fibrosis progression.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18-70 with a BMI over 30 kg/m² and diagnosed with MAFLD and liver fibrosis stages 0-4.

Not a fit: Patients with chronic liver diseases other than MAFLD or those with contraindications to semaglutide will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with MAFLD, potentially improving liver health and reducing the risk of severe liver damage.

How similar studies have performed: Previous studies have shown promise for semaglutide in improving liver health, but this specific real-world application is novel.

Eligibility criteria

Inclusion Criteria:

* Informed consent obtained before performing any research-related action. Research-related procedures include any procedures conducted within the framework of this study, including activities to assess eligibility criteria for participation in the study.
* Body Mass Index (BMI) \> 30 kg/m².
* CAP test result \> 238 dB/m based on steatometry performed no later than 3 months before the patient is included in the study.
* Age 18-70 years at the time of signing the informed consent.

Exclusion Criteria:

* Any contraindication to the appointment of semaglutide.
* Documented reasons for chronic liver disease other than non-alcoholic fatty liver disease (NAFLD).
* Positive test result for HBsAg, HIV antibodies, or positive test result for HCV-RNA.
* Presence of ascites, bleeding from esophageal varices, hepatic encephalopathy, spontaneous bacterial peritonitis, or liver transplantation at the time of screening or a history of these conditions.
* ALT activity \> 5 times the upper limit of normal (ULN).
* AST activity \> 5 times the ULN.
* Alkaline phosphatase activity \> 2 times the ULN at screening.
* International Normalized Ratio (INR) of prothrombin time ≥ 1.35 at screening.
* MELD score \> 12 points at screening.
* Platelet count less than 150,000 per microliter of blood, unless it reflects the patient's usual platelet level, and the patient does not have a diagnosis of portal hypertension in the investigator's opinion.
* Treatment with GLP-1 receptor agonists within 90 days prior to the screening visit.
* Treatment with hypolipidemic drugs or weight loss medications, whose dosage has not been stable, in the investigator's opinion, for 90 days prior to the screening visit.
* Previous or planned (during the study period) treatment of obesity with surgical intervention or the installation of a special device for weight loss. However, the following procedures are allowed:

  1. Liposuction and/or abdominoplasty, if performed more than 1 year before screening.
  2. Laparoscopic gastric banding, if the band was removed more than 1 year before baseline liver biopsy and screening.
  3. Intragastric balloon placement, if the balloon was removed more than 1 year before baseline liver biopsy and screening.
  4. Duodenojejunal sleeve bypass, if the sleeve was removed more than 1 year before baseline liver biopsy and screening.
* Presence of malignant neoplasms currently or in history within the last 5 years prior to screening. Exceptions include only basal cell or squamous cell skin cancer and any carcinoma in situ.
* History of acute pancreatitis within 180 days prior to inclusion in the study.
* Presence of chronic pancreatitis currently or in history.
* Any of the following: myocardial infarction, stroke, heart failure of NYHA class IV, hospitalization for unstable angina, or transient ischemic attack within the last 90 days before the screening day.
* Any health disorder that, in the investigator's opinion, could jeopardize patient safety or affect compliance with the protocol requirements.

Where this trial is running

Moscow

• Center of Target Therapy LLC. — Moscow, Russian Federation (RECRUITING)

Study contacts

• Principal investigator: Pavel Bogomolov, Prof., PhD, MD — Center of target therapy
• Study coordinator: Pavel Bogomolov, Prof., PhD, MD

Conditions: MAFLD, CTT-003, Semaglutide in MAFLD